Status:
COMPLETED
Efficacy and Safety of SPARC0921 in Subjects With Spasticity
Lead Sponsor:
Sun Pharma Advanced Research Company Limited
Conditions:
Spasticity
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess whether SPARC0921 demonstrate efficacy and safety in the treatment of spasticity.
Eligibility Criteria
Inclusion
- Men and women age 18 years and older
- Able and willing to comply with the protocol, including availability for a scheduled clinic visits
- Willingness and giving of written informed consent
Exclusion
- In relapse or history of unstable course over the prior 30 days prior to the Screening Visit
- Concomitant neurologic conditions causing spasticity
- Has received an investigational drug or device within 30 days that would interfere with the study goals prior to the Screening Visit
- Unable to comply with study procedures in the opinion of the investigator
Key Trial Info
Start Date :
November 14 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 25 2017
Estimated Enrollment :
392 Patients enrolled
Trial Details
Trial ID
NCT01457352
Start Date
November 14 2012
End Date
August 25 2017
Last Update
June 18 2019
Active Locations (73)
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1
SPARC site 6
Gilbert, Arizona, United States
2
SPARC Site 40
Phoenix, Arizona, United States
3
SPARC Site 36
Costa Mesa, California, United States
4
SPARC Site 20
Newport Beach, California, United States